Description
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Job Function:
QualityJob Sub Function:
Business Process QualityJob Category:
ProfessionalAll Job Posting Locations:
Bogotá, Distrito Capital, ColombiaJob Description:
DePuy Synthes is recruiting for a CSV Analyst located in Bogota, Colombia.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
Job Overview
The CSV Analyst – Quality Systems supports Computer System Validation (CSV) activities to ensure that quality‑related computerized systems comply with regulatory requirements, quality system standards, and internal policies. This role plays a key part in maintaining data integrity, system compliance, and audit readiness by supporting validation lifecycle activities across Quality Systems. The position partners closely with Quality, IT, and business stakeholders to enable compliant and reliable system operation.
Key Responsibilities
Support computer system validation activities for quality‑related systems in accordance with regulatory and internal requirements.
Execute validation lifecycle activities including planning, risk assessment, testing, documentation, and maintenance.
Support development and maintenance of validation documentation such as protocols, reports, and traceability matrices.
Partner with Quality Systems, IT, and business teams to ensure compliant system implementation and change management.
Support data integrity assessments and ensure adherence to data governance principles.
Assist with audit and inspection readiness related to computerized systems and validation activities.
Monitor validation status, issues, and risks and support corrective and preventive actions.
Contribute to continuous improvement initiatives to strengthen CSV processes and efficiency.
Qualifications
Education:
Bachelor’s degree in Computer Science, Engineering, Information Systems, Life Sciences, or a related discipline (required).
Advanced degree in a technical or quality‑related field (preferred).
Experience and Skills:
Required:
Typically 2-4 years of experience supporting computer system validation or quality systems in a regulated industry.
Working knowledge of CSV principles, validation lifecycle, and regulatory expectations.
Experience supporting audits, inspections, or compliance assessments involving computerized systems.
Strong documentation skills with attention to detail and data integrity.
Ability to collaborate effectively with cross‑functional technical and quality teams.
Preferred:
Experience in medical devices, pharmaceuticals, or other highly regulated industries.
Familiarity with GxP requirements and data integrity principles.
Experience working in a global or matrixed organization.
Exposure to electronic quality management systems (eQMS).
CSV or quality‑related certifications.
Other:
Language: Spanish and English required.
Travel: Limited; occasional domestic travel.
Certifications: CSV or Quality certifications preferred but not required.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
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Required Skills:
Preferred Skills:
Business Behavior, Business Process Management (BPM), Business Requirements Analysis, Coaching, Compliance Management, Cross-Functional Collaboration, Data Reporting, Detail-Oriented, Execution Focus, Goal Attainment, Leverages Information, Problem Solving, Process Optimization, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Technical Writing